VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PROSTATIC SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS LIQUIMMUNE (LIA) QUALITY CONTROL (QC) FLUID USING VITROS PSA REAGENT LOT 4580 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE MAS RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMER'S BASELINE MEAN. MAS LEVEL 2 VITROS PSA RESULTS OF 1.95, 1.94, 1.97, 2.02, AND 1.97 NG/ML VS. THE EXPECTED PSA RESULT OF 2.894 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED, THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS PROSTATIC SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS LIQUIMMUNE (LIA) QUALITY CONTROL (QC) FLUID USING VITROS PSA REAGENT LOT 4580 TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE MAS RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMER'S BASELINE MEAN. THE ASSIGNABLE CAUSE OF THE EVENT WAS SUBOPTIMAL CALIBRATIONS DUE TO USER ERROR. ACCEPTABLE VITROS PSA PERFORMANCE WAS OBTAINED AFTER A CALIBRATION EVENT USING AN ALTERNATE SET OF THE SAME LOT OF CALIBRATORS, WITH NO ADDITIONAL ACTIONS TAKEN TO OPTIMIZE THE VITROS 5600 INTEGRATED SYSTEM. THE CUSTOMER CONFIRMED THAT THE ATYPICAL CALIBRATIONS WERE ALL PERFORMED USING THE SAME SET OF CALIBRATORS, AND THAT THE AFFECTED CALIBRATOR FLUID LIKELY SAT OUT FOR TOO LONG ON THE VITROS 5600 ANALYZER PRIOR TO THE CALIBRATION EVENTS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS PSA REAGENT LOT 4580. AN INSTRUMENT RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT AS POST-CALIBRATION QC WAS ACCEPTABLE AFTER THE CUSTOMER RECALIBRATED USING A FRESH SET OF VITROS PSA CALIBRATOR FLUID, WITHOUT ANY ACTIONS PERFORMED TO OPTIMIZE THE VITROS 5600 INTEGRATED SYSTEM.